Global Medtech Guidance Tracker: April 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-two guidance documents have been posted on the tracker since its last update.
You may also be interested in...
Singapore drives much of the medtech regulatory and policy thought leadership in the ASEAN region, as shown in its regulatory collaboration with Thailand and actions on cybersecurity and packaging waste.
In some cases, a “substantial” change to a clinical investigation will mean having to start anew. Industry is in urgent need of clarification of the term. But does latest EU guidance help sufficiently?
The UK medicines regulator has made changes to its guideline on pharmacovigilance procedures to ensure it can continue receiving all necessary safety information in a timely manner now that it has left the EU. It has also explained the safety reporting procedures for products marketed in Northern Ireland, which are still governed by EU medicines regulations.